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NCT00565058 · ClinicalTrials.gov registry record · Phase 2

Combination of GTI-2040 and Cytarabine in the Treatment of Refractory and Relapsed Acute Myeloid Leukemia (AML)

A Phase 2 study, sponsored by Aptose Biosciences.

Completed
Registry status
Phase 2
Development phase
27
Enrollment target

NCT00565058: Completed Phase 2 study, sponsored by Aptose Biosciences.

NCT00565058 is a Phase 2 study that has completed, run by Aptose Biosciences. The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00565058, a Phase 2 study, has completed, sponsored by Aptose Biosciences.

COMPLETED
Registry status
Phase 2
Development phase
27 participants
Enrollment target

Study Summary

This is a Phase II trial conducted at multiple centers for evaluation of the pharmacodynamic activity and the overall response rate contributed by the combination agents of GTI-2040 and High Dose Cytarabine (HiDAC) in Refractory and Relapsed Acute Myeloid Leukemia (AML).

Primary Outcome

Overall Response was defined as whether or not the patient achieved complete remission (CR) and CR with incomplete blood count recovery (CRi) while on the study.

Interventions

  • BIOLOGICAL GTI-2040

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2007-08
Est. Completion 2010-02
Phase Phase 2
Aptose Biosciences

7 total trials

What the finished NCT00565058 record still lists

NCT00565058 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).

The record links to 0 conditions, and to 1 intervention - of which GTI-2040 is the first listed.

NCT00565058 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00565058 about?

NCT00565058 is a clinical study titled "Combination of GTI-2040 and Cytarabine in the Treatment of Refractory and Relapsed Acute Myeloid Leukemia (AML)". This is a Phase II trial conducted at multiple centers for evaluation of the pharmacodynamic activity and the overall response rate contributed by the combination agents of GTI-2040 and High Dose Cytarabine (HiDAC) in Refractory and Relapsed Acute Myeloid Leukemia (AML).

What is the current status of trial NCT00565058?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2007-08. Estimated completion is 2010-02.

What interventions are being tested in trial NCT00565058?

The interventions under investigation include: GTI-2040 (BIOLOGICAL).

Who is sponsoring clinical trial NCT00565058?

This trial is sponsored by Aptose Biosciences, which has 7 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00565058's enrollment target sits among peer trials

27 1697th of 2000 higher than 293 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00565058, the US trial registry maintained by the National Library of Medicine. NCT00565058 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.